Temperature Mapping - Kevin Loomis
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Transcript of Temperature Mapping - Kevin Loomis
Temperature MappingEquipment, Procedures and Compliance
-Kevin Loomis
Sr Validation EngineerPanasonic Healthcare Corporation of NA
Temperature Mapping 101
Equipment and facilities are temperature mapped to verify that they have the ability to meet specified performance characteristics. Specifications are established using URS, DS, FS, regulatory compliance criteria and established specifications for the products of the application.
Planning
Step 1 – Determine Critical Mapping Points
Step 2 – Determine Sample Rate
Step 3 – Establish Data Logger Criteria
Step 4 – Place Loggers at Pre Determined Points
Step 5 – Capture, Retrieve and Evaluate Logged Data
Step 6 – Document Processes (and Repeat?)
Regulatory References and Guidesfor Temperature Mapping
PIC/S GMP Guide Part I: Basic
Requirements for Medicinal
Program Sections 3.19 and 4.9
ISPE Good Practice Guide –Cold Chain Management (2011)
ISPE Controlled Temperature Chamber Mapping (2012)
ICH Q10 Pharmaceutical Quality
System (2009)
PIC/S GMP Guide Part II: Basic
Requirements for Active
Pharmaceutical Ingredients
Sections 7.42 and 10.1
21 CFR Part 820 cGMPs for Medical Devices
21 CFR Part 820.150 Storage
PDA Technical Report No. 52 –
Guidance for Good Distribution
Practices for the Pharmaceutical
Supply Chain (2011)
21 CFR Part 211 cGMPs for Finished Pharmaceuticals
USP Chapter 1079 Monitoring
Devices – Good Storage and
Shipping Practices (under revision
2011)
21 CFR Part 210 cGMPs for Manufacturing, Processing or Holding of Drugs
Many guides tell you why to map, but don’t tell you how to map!
Reference ISPE doc above & IEC 60068-3-11 for methodology.
Temperature Mapping - Basic Equipment
Sensors & Systems
PRTDs, Thermocouples or Thermistersconnected to a recording device.
(NIST/ISO17025 Calibrated)
Softwarefor Data, Graphs and Analysis
(21 CFR Part 11 Compliant)
Differences in Equipment
• Wired and Wireless
• Loggers and Live
• Sensors
• Software
Equipment Advantages and Disadvantages
• Wireless “loggers” are easy to set up, but can’t be monitored live.
• Wireless “transmitters” can be monitored live, but signal loss is a concern.
• Wired systems are robust, but often create gaps in chamber seals. Limited to sensor wire length.
• Integrated software may be easy to use, but may not be regulatory compliant.
Sensors
Sensor types should be acceptable for the accuracy and range of the device/system being mapped.
Good for incubators, refrigerators, and freezers.
1.0C or 0.75%
1.0C or 1.5%
>0 to 350C
-200 to 0C
T
OK for refrigerators and freezers, unacceptable for incubators.
2.2C or 0.75%
2.2C or 2.0%
>0 to 1250C
-200 to 0C
K
OK for refrigerators, unacceptable for incubators and not rated for freezers.
2.2C or 0.75%>0 to 750CJ
ApplicationStandard Tolerance
Standard Range
TC
Note: A calibrated mapping system will have increased accuracy to that of standard.
Sensor Placement
Placement should follow risk based approach using design considerations and expected use.
Location considerations follow the same methodology regardless of chamber size.
Refrigerators, Freezers and Cold Rooms
• Use forced air flow through evaporator and ducting to remove heat.
• Proper air flow is essential to uniformity and temperature control.
Cold Wall Units
• Remove heat using evaporator coils encased in the chamber walls.
• Not subject to air flow issues.
• Uniformity determined by efficiency of refrigerant.
Incubators and Ovens
• Heating elements, and fans work together to
control temperature and achieve uniformity.
• Like refrigerators, proper air flow is essential.
Autoclaves
• Mapping should capture temperature and pressure.
• Software may assist in determining lethality.
Warehouses, Stability and Dry Storage Chambers
• Temperature and Humidity data should be captured.
• Proper air flow is essential.
Uniformity Testing
• Temperature mapping data helps determine areas in the chamber that may not meet specification.
Dynamic Testing
• Open Door testing gives chamber characteristics during normal use.
• Power Failure testing gives chamber characteristics during failure and recovery conditions.
Loaded versus Empty Chambers
• Empty chambers typically give “Worst Case”performance characteristics.
• Loaded chambers typically produce better data as the mass aids in buffering temperature fluctuations.